Amylin (AMLN) shareholders got a much-needed bit of good news Thursday evening, as the company reported that an FDA-mandated cardiac safety study of the company's one-weekly diabetes drug Bydureon reported positive results. With this information in hand, Amylin's partner Lilly (LLY) should be in place to submit a new application with the FDA in the third quarter of 2011 with possible approval in the second half of 2012.
tQT Looks A-Ok
Among the issues cited by the FDA when it rejected Bydureon back in October of 2010 was the risk that exenatide (the active ingredient) might cause QT prolongation. In simple English, the QT interval is the time that it takes the heart to repolarize (or recharge) between beats. If that interval gets too long, a number of bad things can happen to a person – including palpitations, fainting, and sudden death brought about by ventricular fibrillation and cardiac arrest.
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Amylin Wins A Battle, But The War Goes On
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